Kit comprising a medical fixing element and a device for placing said fixing element

ABSTRACT

The kit ( 1 ) comprises a needle ( 3 ) for placing the fixing element ( 2 ), and the fixing element ( 2 ) comprises at least one stop part ( 5 ) and a threaded deformable part ( 7 ) joined to said stop part ( 5 ). According to the invention, the needle ( 3 ) and the fixing element ( 2 ) comprise means ( 3, 10; 30 ) for detachably connecting the stop part ( 5 ) to the proximal part ( 15 ) of the needle ( 3 ), said connection being solid enough to enable the stop part ( 5 ) to remain integral with the needle ( 3 ) during the manipulation of the kit ( 1 ) when said kit ( 1 ) is handled, also enabling it to be introduced into the body of a patient and enabling the needle ( 3 ) to be introduced into a wall ( 50 ), said connection, however, being able to be released when a traction force is exerted upon the needle ( 3 ), in the direction in which the needle is inserted, beyond a force threshold which is greater than the stress exerted upon the fixing element ( 2 ) as a result of said manipulation, whereby release of the fixing element enables the stop part ( 5 ) to be brought into a non-deformed position by means of elastic recall of said connection.

The present invention relates to a kit comprising a medical fixingelement and a needle for placing this fixing element. It also relates toa fixing element able to be used with this needle.

It is known to fix a prosthetic element or component, in particular aparietal reinforcement, to an anatomical wall, in particular to anabdominal wall, by means of at least one fixing element which is in thegeneral shape of an H, that is to say has two stop bars joined to oneanother by a flexible central rod. The fixing element can pass throughthe wall, in which case one of the stop bars bears against theprosthetic component while the other stop bar bears against the wall onthe opposite side from the prosthetic component; it is also possible forthe fixing element not to pass through the wall, in which case saidother stop bar is then anchored inside this wall.

Such a fixing element can also be used to join two walls of the body ortwo anatomical parts.

U.S. Pat. No. 5 203 864 (cf. FIG. 17), No. 5,320,633 (cf. FIG. 1D) orNo. 4,696,300 (cf. FIGS. 2 a, 2 b) illustrate this type of fixingelement and these types of fixing.

There are different types of devices available for placing these fixingelements.

A first type of device comprises a hollow needle which can be engagedthrough the wall or walls to be fitted and which has a distal opening.The stop bars of the fixing elements can be folded back parallel to thecentral rod in such a way that these fixing elements can be engaged inthe cavity of the needle. The device also comprises a proximal pusherwhich is able to slide in the needle in order to press against thefixing element or fixing elements contained therein so as to selectivelyrelease the most distal fixing element.

A second type of device also comprises a hollow needle, but this needleis slit laterally and receives only one of the stop bars of each fixingelement, the lateral slit allowing said central part and the other stopbar of each fixing element to protrude from the side of the needle.

The document U.S. Pat. No. 4,935,028 describes a surgical suturingsystem permitting closure of a wound or of an incision, particularly inthe cornea, and including a support disk, a filiform part and a needle,the support disk being joined to one end of the filiform part and theneedle being joined to the other end of this filiform part. Afterinsertion into the cornea, the needle is separated from the filiformpart or is cut, the corresponding adjacent end of this filiform partbeing curved to form an anchor, or receiving a stop head.

With the system according to this earlier document, the need to cut theneedle from the filiform part and then to anchor or lock the end of thisfiliform part is something of a practical constraint, making this systemincompatible with the use of minimally invasive techniques such aslaparoscopy. Moreover, tensioning of the fixing element, which isnecessary to ensure that the two walls to be joined are held tightlyagainst one another, is difficult to achieve with this system. Such ahold is imperative in some cases, in particular for complete tissueintegration of an abdominal wall reinforcement in the abdominal walltreated.

The document EP 1 090 590 describes a needle having a lateral slit andcomprising a releasable fixing element. The system according to saiddocument too is unable to permit the aforementioned tensioning of thefixing element.

The present invention aims to remedy the shortcomings of the prior art.

It is therefore an object of the invention to make available a kit forplacing a fixing element with tension, in such a way as to ensure thatthe two walls to be joined are held tightly against one another.

Another object of the invention is to make available a kit particularlydesigned to hold an abdominal wall reinforcement pressed intimatelyagainst the abdominal wall treated, so as to ensure good tissueintegration of this reinforcement to this abdominal wall.

A supplementary object of the invention is to make available a kit whichis perfectly compatible with the use of minimally invasive techniquessuch as laparoscopy.

A further object of the invention is to make available a kit ofparticularly simple construction and use, so as to offer extendedpossibilities of application.

A further object of the invention is to make available a kit which canbe disposed off after one use.

The kit in question comprises, in a manner known per se, a medicalfixing element and a needle for placing this fixing element, the needlebeing able to be engaged through, or within the thickness of, the wallor walls intended to be fitted with the fixing element, and this fixingelement having at least one stop part, able to bear against a wall, anda filiform deformable part joined to said stop part; the fixing elementis elastically deformable at the area of the connection between saidstop part and said filiform deformable part such that the stop part ismovable relative to the filiform deformable part between a position ofelastic deformation of said connection, in which the stop part and thefiliform deformable part can be substantially inscribed within the crosssection of the needle, and a position of nondeformation, in which thestop part is able to bear against the wall or walls and ensure anchoringof the fixing element.

According to the invention, the needle and the fixing element comprisemeans for detachable connection of the stop part to the proximal part ofthe needle, this connection being sufficiently robust to ensure that thestop part remains integral with the needle during maneuvers of the kitwhen taking hold of this kit, introducing it into the body of thepatient, and inserting the needle into said wall, but being releasablewhen a traction is exerted on the needle, in the direction of insertionof the needle, beyond a force threshold greater than the stressesexerted on the fixing element by said maneuvers, the release of thefixing element making it possible to bring said stop part to theposition of nondeformation, by means of elastic return of saidconnection.

The fixing element is thus released following a traction exerted on theneedle, in the direction of insertion of this needle, which permits acertain tensioning of the fixing element with respect to the wall orwalls to be fitted. This tensioning ensures that two walls to be joinedare held tightly against one another, in particular an abdominal wallreinforcement and the abdominal wall treated.

The needle has a particularly simple structure and small size, makingthe kit in question very easy to use both with laparoscopy techniquesand with direct surgical access.

The anchoring can be carried out by accessing the wall to be fitted inthe area of the face of this wall intended to receive the prostheticelement, or can be carried out transcutaneously.

The simplicity of the structure of the needle also means that the kitaccording to the invention can be designed to be disposable, it beingpossible for the needle to be discarded after one use. A series of suchkits could therefore be packed in a sterile package, advantageouslydesigned to constitute, after opening, a presentation rack from whicheach kit can easily be removed in succession. This package can inparticular be of the blister type.

This same simplicity of structure additionally means that the needle canbe given all suitable shapes. In particular, the needle can have acurved or arched distal part, similar to that of suturing needles.

This curved or arched shape makes it possible in particular to carry outthe fixing operation with an H-shaped fixing element as mentioned above,in which the two stop bars of the fixing element are situated on thesame face of a tissue wall, in particular in the area of a parietalreinforcement, said deformable filiform part being engaged within thethickness of the wall in a curved trajectory corresponding to thetrajectory of the needle in this wall during placing of the fixingelement. Two stop bars are thus positioned against the prostheticelement to be implanted, in particular a parietal reinforcement, whichpermits reinforced and efficient anchoring of this element.

According to one possible embodiment of the invention, the needle has aninner cavity opening out in its proximal part, and it receives said stoppart of the fixing element in this cavity.

Said means for detachable connection can then comprise the wall of theneedle delimiting said cavity and the stop part of the fixing element;the dimensions of said cavity and of said stop part are then determinedsuch that friction exists between this stop part and this wall of theneedle.

Said means for detachable connection can also comprise, in addition toor alternatively to the friction connection cited above, one or morebosses projecting inside the cavity and able to form a “hard point”which has to be passed by said stop part in order to permit release ofthe fixing element.

Each boss can in particular be formed by a stamped-in part in theproximal end zone of the needle.

According to one embodiment of the invention in this case,

-   -   the needle has a proximal cavity having a constant diameter        along a proximal portion intended to receive the fixing element        and having a progressive reduction of this diameter along a        distal portion;    -   the fixing element comprises a distal bar, a proximal bar and an        intermediate part joining these bars to one another; the distal        bar has a flange whose diameter is slightly smaller than the        diameter of said proximal portion of the cavity, so that this        flange can be introduced into and can slide in this proximal        portion as far as the distal portion of this cavity in which        this flange becomes wedged; the length of the intermediate part        is such that the proximal bar comes into contact with the        proximal end of the needle when the flange is in a position        producing sufficient wedging of this flange.

The proximal bar coming into abutment against the proximal end of theneedle thus makes it possible to define a specific degree of insertionof the flange in the cavity of the needle, corresponding to the idealwedging to be obtained. This ideal wedging is sufficient to resist theaforementioned friction to which the fixing element is exposed, but isinsufficient to risk causing damage to the fixing element when it isdesired to cancel the connection between the needle and the fixingelement.

According to another possible embodiment of the invention, the kitcomprises a flexible filiform part joined to the proximal end of theneedle and to a sleeve receiving said stop part of the fixing element.

The flexible filiform part thus increases the possibilities of mobilityof the needle relative to the fixing element, which makes it easier tomaneuver the needle with a view to inserting it through the wall orwalls to be fitted, and permits use of a conventional suturing needle.This same flexible filiform part ensures that the fixing element issituated at a distance from the needle during maneuvering of thisneedle, so as to eliminate any risk of premature separation of thefixing element and needle during these maneuvers.

A simple way of obtaining the kit according to the invention in thiscase is to use a tube made of heat-shrinkable material, in particularpolytetrafluoro-ethylene (PTFE), and to heat-shrink this material alongthe greater part of this tube in order to form said flexible filiformpart, without heat-shrinking the rest of this tube intended to form saidsleeve.

In this embodiment of the invention, said means for detachableconnection can comprise the respective dimensions of the sleeve and ofthe fixing element, these dimensions being such that friction existsbetween the fixing element and the sleeve when this fixing element isinserted into this sleeve. These dimensions can in particular derivefrom the judicious choice of the diameter of the tube made ofheat-shrinkable material.

These same means for detachable connection can comprise a lateralopening which is formed in the sleeve and in which a portion of thefixing element is engaged detachably, in particular an end of said stoppart. The separation of the fixing element and of the sleeve can then beachieved by tearing the wall of the sleeve starting from this slot.

Said means for detachable connection can also comprise a thread presentin the sleeve and engaged detachably around a part of the fixingelement. This thread can in particular form a loop around a part of thefixing element and is breakable. In the aforementioned case of using atube made of heat-shrinkable material, this thread is simply engaged inthe tube before heat-shrinking is carried out.

According to another possible embodiment of the invention, the needleand said stop part of the fixing element are connected to one another bya material bridge dimensioned so as to rupture beyond said forcethreshold. In this case, the needle and the fixing element can be moldedin one and the same piece of an appropriate material.

Said stop part of the fixing element can be in the form of a bar joinedto said deformable filiform part approximately at its central zone.

The fixing element can comprise a single stop part or can comprise twostop parts joined to one another by said deformable filiform part.

These two stop parts permit the reinforced and efficient anchoringmentioned above.

The two stop parts can in particular be in the form of bars. Theproximal stop part, given that it is not to be introduced into theneedle, can have any suitable shape differing from a bar shape andcapable of improving its ability to form a stop. For example, it can bein the shape of a ball, disk or ring.

Moreover, by virtue of the invention, there are no limitations to thelength it is possible to give to said deformable filiform part; thisdeformable filiform part can in particular be formed by a thread thatcan be used to make a suture, the stop parts then being used to formknots; it can also have a length which is such that several successivepasses of the needle through the wall or walls to be fitted arepossible. In this second case, the deformable filiform part can have arelative rigidity which, when it is inserted in a curved or undulatingtrajectory into the wall or walls, gives it a capacity for elasticreturn to its rectilinear shape. This return capacity ensures that aprosthetic component is held pressed against the wall which has receivedthe fixing element. Alternatively, for the same purpose, the deformablefiliform part can have a longitudinal elasticity.

The fixing element can additionally be made of a bioabsorbable material.

To ensure that the invention is clearly understood, it is againdescribed below with reference to the attached diagrammatic drawingwhich shows, by way of nonlimiting examples, several possibleembodiments of the kit according to the invention and various possibleembodiments of the fixing element which this kit includes.

FIG. 1 is a side view, before assembly, of the needle and of the fixingelement included in this kit, according to a first embodiment;

FIG. 2 is a similar view to FIG. 1, after assembly;

FIG. 3 is a view of the fixing element according to arrow III in FIG. 1;

FIGS. 4 through 7 are side views of said kit and of a tissue wall inwhich the fixing element is intended to be placed, showing,respectively, four successive steps involved in placing this fixingelement in this wall;

FIGS. 8 through 11 are side views of said kit in an alternativeembodiment and of a tissue wall in which the fixing element is intendedto be placed, showing respectively four successive steps involved inplacing this fixing element in this wall;

FIG. 12 is a view is a view of said kit, similar to FIG. 2, according toanother embodiment of the fixing element;

FIGS. 13 through 15 are side views of said kit and of a tissue wall inwhich the fixing element is intended to be placed, showing threesuccessive steps involved in placing this fixing element in this wall;

FIG. 16 is a view is a view of said kit, similar to FIG. 12, accordingto an alternative embodiment;

FIG. 17 is a view is a view of said kit, similar to FIG. 12, accordingto another embodiment;

FIG. 18 is a view of said kit, similar to FIG. 2, according to analternative embodiment of the fixing element;

FIG. 19 is a view of said kit, similar to FIG. 2, in another alternativeembodiment of the fixing element, and

FIG. 20 is a view of said kit, similar to FIG. 2, in another embodiment.

For simplification, the parts or elements of the first embodiment whichare found again in the other embodiments or variants will be designatedby the same reference numbers and will not be described anew.

FIGS. 1 and 2 show a kit 1 comprising a medical fixing element 2 and aneedle 3 for placing this fixing element 2.

The fixing element 2 is molded in one piece from a deformable syntheticmaterial which may be bioabsorbable. It comprises a first stop bar 5, asecond stop bar 6, and a filiform intermediate part 7 joining these bars5, 6 to one another.

The fixing element 2 is shown in FIG. 1 in its neutral form, that is tosay in the absence of any deformation. In this shape, the bars 5, 6 forman angle of approximately 90 degrees between them, and the intermediatepart 7 is oriented with respect to the bars 5, 6 substantiallyperpendicular to the bisecting line of the angle formed by these bars 5,6.

Referring to FIG. 2, it will be seen that the deformability of theintermediate part 7 allows the bar 5 to be folded back in thecontinuation of this intermediate part 7; referring to FIG. 7, it willbe seen that this same deformability allows the bars 5, 6 to bepositioned substantially in the same plane after the fixing element 2has been placed on the tissue wall 50.

The bar 5 has a diameter greater than that of the intermediate part 7,thus giving it a longitudinal rigidity greater than that of this part 7,and it is joined to the latter in the area of its central portion. At adistal end (considered with reference to the direction of engagement ofthe needle in the wall 50), it comprises a transverse flange 10 of adefined diameter which will be explained below. At its proximal end, ithas a bevel 11. As is shown in FIG. 2, this bevel 11 forms a clearanceallowing the bar 5 to be folded back against the part 7 notwithstandinga central bulge 12 which this part 7 possesses.

The bar 6 also has a diameter greater than that of the intermediate part7, so as to have a longitudinal rigidity greater than that of this part7, and it is also joined to the latter at its central portion. It has apurely cylindrical shape.

In addition to its aforementioned deformability, orientation and bulge12, the intermediate part 7 has a defined length which will be explainedbelow.

The needle 3 is made of stainless steel. It has a rectilinear proximalpart 15 of tubular structure and an arched distal part 16. The diameterof the needle 3 progressively decreases in the direction toward thedistal end 17 of this needle, this decrease in diameter starting at thedistal end of the proximal part 15.

The proximal part 15 thus defines a cavity 20 which has a constantdiameter along a wide proximal portion and has a progressive decrease inthis diameter along a distal portion. As is shown in FIG. 2, theproximal portion of the cavity 20 is able to receive the bar 5 and theintermediate part 7 when this bar 5 is folded back in the continuationof this intermediate part 7; the diameter of the flange 10 is slightlysmaller than the diameter of the proximal portion of the cavity 20, sothat this flange 10 can be introduced into and slide in said proximalportion of this cavity 20 as far as the distal portion of this cavity20, in which this flange 10 becomes wedged.

As is also shown in FIG. 2, the length of the intermediate part 7 issuch that the bar 6 comes into contact with the proximal end 21 of theneedle 3 when the flange 10 is in a position producing sufficientwedging of this flange 10 in the cavity 20. This sufficient wedging issuch that it produces a detachable connection of the fixing element 2 tothe proximal part 15 of the needle 3. This connection is sufficientlyrobust to ensure that the fixing element 2 remains secured to the needle3 during maneuvers of the kit 1 when taking hold of said kit 1,introducing it into the patient's body and inserting the needle 3 intothe wall 50 to be fitted, but is releasable when the fixing element 2bears against the wall 50 and a manual traction is exerted by thepractitioner on the needle 3.

The needle 3 additionally has, in its proximal end portion, a boss 25projecting into the inside of the cavity 20 and formed by a stamped-inpart in the wall of the needle 3. This boss 25 is able to constitute a“hard point” which has to be passed by the flange 10 in order to permitseparation of the fixing element 2 from the needle 3.

In practice, and as is shown in FIGS. 4 through 7, a parietalreinforcement 51 is placed along the wall 50 to be reinforced, and thekit 1 is then brought near to this wall 50.

The arched portion 16 of the needle 3 is then inserted partially throughthe reinforcement 51 and the wall 50 (FIG. 4) in a circular movementcentered substantially on the center generating this arched part 16, inaccordance with the traditional use of a curved suturing needle.

The distal portion of the arched part 16 emerging from the wall 50 andreinforcement 51 following this insertion is then gripped and pulleduntil the proximal part 15 of the needle engages in the wall 50 (FIG.5). This engagement brings the bar 6 to bear against the reinforcement51 and causes it to unwedge the flange 10, thereby allowing theintermediate part 7 to leave the cavity 20 as the part 15 slides in thewall 50.

The needle 3 is then gradually extracted from the wall 50 andreinforcement 51 by traction exerted on it in a direction parallel tothat occupied by the part 15 in FIG. 5, until complete extraction (FIG.6). The flange 10 then comes up against the boss 25.

A traction is then exerted on the needle 3 in a direction parallel tothat occupied by the part 15 in FIG. 6, to allow the flange 10 to movepast the boss 25. This traction allows the bar 5 to be extracted fromthe cavity 20 by moving it away from the reinforcement 51, so that thisbar 5 then comes to lie, through elastic return of the intermediate part7, against the reinforcement 51 and presses this reinforcement 51against the wall 50 (FIG. 7). The needle 3 is then removed anddiscarded.

The operations described above are repeated as many times as isnecessary in different locations of the reinforcement 51 to ensure thatthis reinforcement 51 is fixed completely to the wall 50. A new kit 1 isused for each placement of a fixing element 2.

FIGS. 8 through 11 show a kit 1 very similar to that described above,except that the needle 3 is rectilinear and is engaged through thereinforcement 51 and the wall 50, the bar 5 being anchored inside thiswall 50 once it is separated from the needle 3.

FIGS. 12 through 14 show alternative embodiments of the fixing element 2and a second embodiment of the kit 1. The elements already described,which are found again in an identical or similar manner in thesefigures, are designated by the same reference numbers.

FIG. 12 shows a kit 1 in which the needle 3 is a conventional suturingneedle, that is to say comprising a proximal end able to be crimped on asuture thread.

In this case, the kit 1 comprises a flexible filiform part 22, one endof which is joined to the proximal end of the needle 3 by crimping, andthe other end of which is connected to a sleeve 23 receiving the stopbar 5 and the filiform part 7 of the fixing element 2.

The part 22 and the sleeve 23 are made from a tube of heat-shrinkablematerial, in particular polytetra-fluoroethylene (PTFE), heat-shrinkingof this material being carried out on that part of said tube intended toconstitute the part 22. The detachable connection between the sleeve 23and the fixing element 2 is obtained by judicious choice of the diameterof the tube of heat-shrinkable material, this diameter being such thatfriction exists between the fixing element 2 and the sleeve 23 when thisfixing element is inserted into this sleeve.

As is shown in FIGS. 13 through 15, the part 22 increases thepossibilities of mobility of the needle 3 relative to the fixing element2, making maneuvering of the needle easier. This part 22 also allows thefixing element 2 to be situated at a distance from the needle 3 duringmaneuvering of this needle, so as to eliminate any risk of prematureseparation of the fixing element 2 and needle 3 during these maneuvers.

In the case of the kit 1 shown in FIG. 16, a lateral opening 24 isformed in the sleeve 23, and an end of the stop bar 5 is engageddetachably in this slot 24. The separation of the fixing element 2 andsleeve 23 can then be obtained by partial or complete tearing of thewall of the sleeve starting from this slot 24.

The kit 1 shown in FIG. 17 also comprises a part 22 and a sleeve 23formed by a tube of heat-shrinkable material. In this case, a breakablethread 25 forming a loop around the bar 5 is engaged in the tube beforeheat-shrinking. This thread 25 permits the detachable connection betweenthe sleeve 23 and the fixing element 2.

In the case of FIG. 18, the intermediate part 7 has a length such thatseveral successive passes of the needle 3 through the wall 50 arepossible.

In the case of FIG. 19, the intermediate part 7 is formed by a threadwhich can be used to form a suture.

This thread is wound on a bobbin the time of introduction of the kit 1into the patient's body.

In the case of FIG. 20, the needle 3 and the fixing element 2 are moldedin one and the same piece of material. The needle 3 and the bar 5 arethen joined to one another by a material bridge 30 dimensioned so as torupture beyond the aforementioned force threshold.

As will be evident from the foregoing, the invention provides a kit 1which has numerous advantages compared to similar systems in the priorart. The decisive advantage of this kit 1 lies in its simple structureand straightforward function and the fact that it offers extendedpossibilities of use. In particular, this kit is very easy to use bothwith laparoscopy techniques and with direct access techniques; anchoringcan be achieved by accessing the wall to be fitted, in the area of theface of said wall intended to receive the prosthetic element, or it canbe achieved transcutaneously; the kit 1 can be designed to be discardedafter one use, and makes it possible to give the distal part of theneedle any suitable shape, in particular a curved or arched shape, andto use different types of fixing elements.

It goes without saying that the invention is not limited to theembodiment described above by way of example and that instead itencompasses all alternative embodiments falling within the scope ofprotection defined by the attached claims. Thus, the fixing element 2can be used not only to fix a prosthetic element or component, inparticular a parietal reinforcement 51, to an anatomical wall 50, inparticular an abdominal wall, but also to join two anatomical walls ortwo anatomical parts to one another, or to fix any other type ofcomponent or element to such a wall; a straight needle can be used toengage the fixing element through a fold formed in a tissue; the meansfor detachable connection of the fixing element 2 can comprise a slitformed in the proximal end of the needle, giving the needle aflexibility allowing it to retain the fixing element; the curved needlecan be of the “three eighths” type, that is to say having a shapecorresponding substantially to three eighths of a circle; the fixingelement can extend beyond the proximal end of this needle.

1. A kit (1) comprising a medical fixing element (2) and a needle (3)for placing the fixing element (2), the needle (3) being able to beengaged through, or within a thickness of, a wall or walls (50) intendedto be fitted with the fixing element (2), and the fixing element (2)having at least one stop part (5), able to bear against the wall (50),and a filiform deformable part (7) joined to said stop part (5); thefixing element (2) is elastically deformable at an area of a connectionbetween said stop part (5) and said filiform deformable part (7) suchthat the stop part (5) is movable relative to the filiform deformablepart (7) between a position of elastic deformation of said connection,in which the stop part (5) and the filiform deformable part (7) can besubstantially inscribed within a cross section of the needle (3), and aposition of nondeformation, in which the stop part (5) is able to bearagainst the wall or walls (50) and ensure anchoring of the fixingelement (2); the kit (1) being characterized in that the needle (3) andthe fixing element (2) comprise means (3, 10; 30) for detachableconnection of the stop part (5) to a proximal part (15) of the needle(3), the connection being sufficiently robust to ensure that the stoppart (5) remains integral with the needle (3) during maneuvers of thekit (1) when taking hold of the kit (1), introducing it into the body ofthe patient, and inserting the needle (3) into said wall (50), but beingreleasable when a traction is exerted on the needle (3), in thedirection of insertion of the needle, beyond a force threshold greaterthan the stresses exerted on the fixing element (2) by said maneuvers,the release of the fixing element making it possible to bring said stoppart (5) to the position of nondeformation, by means of elastic returnof said connection, the needle (3) has a proximal cavity (20) having aconstant diameter along a proximal portion intended to receive thefixing element (2) and having a progressive reduction of the diameteralong a distal portion; the fixing element (2) comprises a distal bar(5), a proximal bar (6) and an intermediate part (7) joining these bars(5, 6) to one another; the distal bar (5) has a flange (10) whosediameter is slightly smaller than the diameter of said proximal portionof the cavity (20), so that the flange (10) can be introduced into andcan slide in the proximal portion as far as the distal portion of thecavity (20) in which the flange (10) becomes wedged; the length of theintermediate part (7) is such that the proximal bar (6) comes intocontact with the proximal end (21) of the needle (3) when the flange(10) is in a position producing sufficient wedging of the flange (10).2. The kit (1) as claimed in claim 1, characterized in that the needle(3) and the stop part (5) of the fixing element (2) are joined to oneanother by a material bridge (30) dimensioned so as to rupture beyondsaid force threshold.
 3. The kit (1) as claimed in claim 2,characterized in that the needle (3) and the fixing element (2) aremolded in one and the same piece of material.
 4. The kit (1) as claimedin claim 1, characterized in that said means for detachable connectioncomprise: respective dimensions of the sleeve (23) and of the fixingelement (2), these dimensions being such that friction exists betweenthe fixing element (2) and the sleeve (23) when the fixing element (2)is inserted into the sleeve (23); and/or a lateral opening (24) which isformed in the sleeve (23) and in which a portion of the fixing element(2) is engaged detachably, in particular an end of said stop part (5);and/or a thread (25) present in the sleeve (23) and engaged detachablyaround a part (5, 7) of the fixing element (2).
 5. The kit (1) asclaimed in claim 4, characterized in that the thread (25) forms a looparound a part (5, 7) of the fixing element (2) and is breakable.
 6. Akit (1) comprising a needle (3); and a fixing element (2) having atleast one stop part (5), able to bear against a wall (50), and afiliform deformable part (7) joined to said stop part (5), the fixingelement (2) being elastically deformable at the area of the connectionbetween said stop part (5) and said filiform deformable part (7) suchthat the stop part (5) is movable, relative to the filiform deformablepart (7), between a position of elastic deformation of said connection,in which the stop part (5) and the filiform deformable part (7) can besubstantially inscribed within a cross section of a proximal part (15)of the needle (3), and a position of nondeformation, in which the stoppart (5) is able to bear against the wall or walls (50) and ensureanchoring of the fixing element (2); characterized in that the kit (1)includes means (10;30) for detachable connection of the stop part (5) tothe proximal part (15) of the needle (3), the needle (3) having aproximal cavity (20) having a constant diameter along a proximal portionintended to receive the fixing element (2) and having a progressivereduction of the diameter along a distal portion, the connection beingsufficiently robust to ensure that the stop part (5) remains integralwith the needle (3) during maneuvers of the kit (1) when taking hold ofthe kit (1), introducing it into the body of the patient, and insertingthe needle (3) into said wall (50), but being releasable when a tractionis exerted on the needle (3), in the direction of insertion of theneedle, beyond a force threshold greater than the stresses exerted onthe fixing element (2) by said maneuvers, the stop part (5) having aflange whose diameter is slightly smaller than the diameter of theproximal portion as far as the distal portion of the cavity in which theflange becomes wedged, the release of the fixing element making itpossible to bring said stop part (5) to the position of nondeformation,by means of elastic return of said connection, the deformable filiformpart (7) of the fixing element (2) being formed by a thread that can beused to make a suture.
 7. A kit (1) comprising a needle (3); and afixing element (2) having at least one stop part (5), able to bearagainst a wall (50), and a filiform deformable part (7) joined to saidstop part (5), the fixing element (2) being elastically deformable atthe area of the connection between said stop part (5) and said filiformdeformable part (7) such that the stop part (5) is movable, relative tothe filiform deformable part (7), between a position of elasticdeformation of said connection, in which the stop part (5) and thefiliform deformable part (7) can be substantially inscribed within across section of a proximal part (15) of the needle (3), and a proximalpart (15) of the needle (3), and a position of nondeformation, in whichthe stop part (5) is able to bear against the wall or walls (50) andensure anchoring of the fixing element (2); characterized in that thekit (1) includes means (10;30) for detachable connection of the stoppart (5) to the proximal part (15) of the needle (3), the needle (3)having a proximal cavity (20) having a constant diameter along aproximal portion intended to receive the fixing element (2) and having aprogressive reduction of the diameter along a distal portion, theconnection being sufficiently robust to ensure that the stop part (5)remains integral with the needle (3) during maneuvers of the kit (1)when taking hold of the kit (1), introducing it into the body of thepatient, and inserting the needle (3) into said wall (50), but beingreleasable when a traction is exerted on the needle (3), in thedirection of insertion of the needle, beyond a force threshold greaterthan the stresses exerted on the fixing element (2) by said maneuvers,the stop part (5) having a flange whose diameter is slightly smallerthan the diameter of the proximal portion as far as the distal portionof the cavity in which the flange becomes wedged, the release of thefixing element making it possible to bring said stop part (5) to theposition of nondeformation, by means of elastic return of saidconnection, the deformable filiform part (7) of the fixing element (2)having a length such that several successive passes of the needle (3)through the wall or walls (50) to be fitted are possible.
 8. A fixingelement (2) A kit (1) comprising a needle (3); and a fixing element (2)having at least one stop part (5), able to bear against a wall (50), anda filiform deformable part (7) joined to said stop part (5), the fixingelement (2) being elastically deformable at the area of the connectionbetween said stop part (5) and said filiform deformable part (7) suchthat the stop part (5) is movable, relative to the filiform deformablepart (7), between a position of elastic deformation of said connection,in which the stop part (5) and the filiform deformable part (7) can besubstantially inscribed within a cross section of a proximal proximalpart (15) of the needle (3), and a position of nondeformation, in whichthe stop part (5) is able to bear against the wall or walls (50) andensure anchoring of the fixing element (2); characterized in that thekit (1) includes means (10;30) for detachable connection of the stoppart (5) to the proximal part (15) of the needle (3), the needle (3)having a proximal cavity (20) having a constant diameter along aproximal portion intended to receive the fixing element (2) and having aprogressive reduction of the diameter along a distal portion, theconnection being sufficiently robust to ensure that the stop part (5)remains integral with the needle (3) during maneuvers of the kit (1)when taking hold of the kit (1), introducing it into the body of thepatient, and inserting the needle (3) into said wall (50), but beingreleasable when a traction is exerted on the needle (3), in thedirection of insertion of the needle, beyond a force threshold greaterthan the stresses exerted on the fixing element (2) by said maneuvers,the stop part (5) having a flange whose diameter is slightly smallerthan the diameter of the proximal portion as far as the distal portionof the cavity in which the flange becomes wedged, the release of thefixing element making it possible to bring said stop part (5) to theposition of nondeformation, by means of elastic return of saidconnection, characterized in that its filiform part (7) having arelative rigidity which, when it is inserted in a curved or undulatingtrajectory into the wall or walls (50) to be fitted, gives it a capacityfor elastic return to its rectilinear shape.